Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: A post hoc analysis of pooled data

Cardiovascular Diabetology

Volumn 16, Issue 1, 2017, Pages

  Davies, Michael J ^a   Merton, Katherine ^a   Vijapurkar, Ujjwala ^a   Yee, Jacqueline ^a   Qiu, Rong ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Canagliflozin; Cardiovascular disease; Risk factors; SGLT2 inhibitor; Type 2 diabetes mellitus

Indexed keywords

CANAGLIFLOZIN; HEMOGLOBIN A1C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; METFORMIN; PIOGLITAZONE; PLACEBO; SULFONYLUREA; ANTIDIABETIC AGENT;

ADULT; AGED; ARTICLE; BODY WEIGHT; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COMBINATION DRUG THERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG USE; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERTENSION; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; POST HOC ANALYSIS; RISK ASSESSMENT; SYSTOLIC BLOOD PRESSURE; CARDIOVASCULAR DISEASES; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; MIDDLE AGED; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; STATISTICS; TREATMENT OUTCOME;

AGED; CANAGLIFLOZIN; CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; RISK FACTORS; STATISTICS AS TOPIC; TREATMENT OUTCOME;

EID: 85016130739     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/s12933-017-0517-7     Document Type: Article

References (42)

1. International Diabetes Federation. IDF diabetes atlas. 7th ed. Brussels: International Diabetes Federation; 2015.
2. Emerging Risk Factors Collaboration, Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010;375(9733):2215-22.
3. Laakso M. Hyperglycemia and cardiovascular disease in type 2 diabetes. Diabetes. 1999;48(5):937-42.
4. Low Wang CC, Hess CN, Hiatt WR, Goldfine AB. Clinical update: cardiovascular disease in diabetes mellitus: atherosclerotic cardiovascular disease and heart failure in type 2 diabetes mellitus-mechanisms, management, and clinical considerations. Circulation. 2016;133(24):2459-502.
5. Inzucchi SE, Zinman B, Wanner C, Ferrari R, Fitchett D, Hantel S, Espadero RM, Woerle HJ, Broedl UC, Johansen OE. SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials. Diabetes Vasc Dis Res. 2015;12(2):90-100.
6. Johansen OE. Cardiovascular disease and type 2 diabetes mellitus: a multifaceted symbiosis. Scand J Clin Lab Investig. 2007;67(8):786-800.
7. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1):140-9.
8. Wami WM, Buntinx F, Bartholomeeusen S, Goderis G, Mathieu C, Aerts M. Influence of chronic comorbidity and medication on the efficacy of treatment in patients with diabetes in general practice. Br J Gen Pract. 2013;63(609):e267-73.
9. ® (glipizide) TABLETS [package insert]. New York: Roerig; 2008.
10. ® (micronized glyburide tablets) [package insert]. New York: Pharmacia and Upjohn Company; 2010.
11. ACTOS (pioglitazone) tablets for oral use [package insert]. Deerfield: Takeda Pharmaceuticals America, Inc; 2013.
12. Sha S, Devineni D, Ghosh A, Polidori D, Chien S, Wexler D, Shalayda K, Demarest K, Rothenberg P. Canagliflozin, a novel inhibitor of sodium glucose co-transporter 2, dose dependently reduces calculated renal threshold for glucose excretion and increases urinary glucose excretion in healthy subjects. Diabetes Obes Metab. 2011;13(7):669-72.
13. Polidori D, Sha S, Ghosh A, Plum-Mörschel L, Heise T, Rothenberg P. Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013;98(5):E867-71.
14. Rosenthal N, Meininger G, Ways K, Polidori D, Desai M, Qiu R, Alba M, Vercruysse F, Balis D, Shaw W, et al. Canagliflozin: a sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes mellitus. Ann N Y Acad Sci. 2015;1358(1):28-43.
15. Stenlöf K, Cefalu WT, Kim KA, Alba M, Usiskin K, Tong C, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372-82.
16. Lavalle-González FJ, Januszewicz A, Davidson J, Tong C, Qiu R, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582-92.
17. Wilding JP, Charpentier G, Hollander P, Gonzalez-Galvez G, Mathieu C, Vercruysse F, Usiskin K, Law G, Black S, Canovatchel W, et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67(12):1267-82.
18. Forst T, Guthrie R, Goldenberg R, Yee J, Vijapurkar U, Meininger G, Stein P. Efficacy and safety of canagliflozin over 52weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab. 2014;16(5):467-77.
19. Wilding JPH, Blonde L, Leiter LA, Cerdas S, Tong C, Yee J, Meininger G. Efficacy and safety of canagliflozin by baseline HbA1c and known duration of type 2 diabetes mellitus. J Diabetes Complications. 2015;29(3):438-44.
20. Burrows N, Parekh S, Li Y, Geiss L. Prevalence of self-reported cardiovascular disease among persons aged ≥35years with diabetes-United States, 1997-2005. MMWR Wkly. 2007;56(43):1129-32.
21. Jurado J, Ybarra J, Solanas P, Caula J, Gich I, Pou JM, Romeo JH. Prevalence of cardiovascular disease and risk factors in a type 2 diabetic population of the North Catalonia diabetes study. J Am Acad Nurse Pract. 2009;21(3):140-8.
22. Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes: pooled analysis of phase 3 study results. Postgrad Med. 2014;126(3):16-34.
23. Meininger G, Canovatchel W, Polidori D, Rosenthal N. Canagliflozin for the treatment of adults with type 2 diabetes. Diabetes Manag. 2015;5(3):183-201.
24. Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015;31(11):1993-2000.
25. Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Gogo-Jack S, Defronzo RA, Einhorn D, Fonseca VA, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm-2016 executive summary. Endocr Pract. 2016;22(1):84-113.
26. Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014;14(1):37.
27. Sinclair AJ, Bode B, Harris S, Vijapurkar U, Shaw W, Desai M, Meininger G. Efficacy and safety of canagliflozin in individuals aged 75 and older with type 2 diabetes mellitus: a pooled analysis. J Am Geriatr Soc. 2016;64(3):543-52.
28. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts): developed with the special contribution of the European Association for Cardiovascular Prevention and Rehabilitation (EACPR). Eur J Prev Cardiol. 2016;23(11):NP1-96.
29. Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HA, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-96.
30. Betteridge DJ, Gibson JM. Effects of rosuvastatin on lipids, lipoproteins and apolipoproteins in the dyslipidaemia of diabetes. Diabet Med. 2007;24(5):541-9.
31. Holman RR, Paul S, Farmer A, Tucker L, Stratton IM, Neil HA. Atorvastatin in factorial with omega-3 EE90 risk reduction in diabetes (AFORRD): a randomised controlled trial. Diabetologia. 2009;52(1):50-9.
32. Simsek S, Schalkwijk CG, Wolffenbuttel BH. Effects of rosuvastatin and atorvastatin on glycaemic control in type 2 diabetes-the CORALL study. Diabet Med. 2012;29(5):628-31.
33. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-28.
34. ® (empagliflozin) tablets, for oral use [package insert]. Ridgefield: Boehringer Ingelheim Pharmaceuticals, Inc; 2016.
35. Mudaliar S, Alloju S, Henry RR. Can a shift in fuel energetics explain the beneficial cardiorenal outcomes in the EMPA-REG OUTCOME study A unifying hypothesis. Diabetes Care. 2016;39(7):1115-22.
36. Ferrannini E, Mark M, Mayoux E. CV protection in the EMPA-REG OUTCOME trial: a "thrifty substrate" hypothesis. Diabetes Care. 2016;39(7):1108-14.
37. Scheen AJ. Reappraisal of the diuretic effect of empagliflozin in the EMPA-REG OUTCOME trial: comparison with classic diuretics. Diabetes Metab. 2016;42(4):224-33.
38. Heerspink HJ, Perkins BA, Fitchett DH, Husain M, Cherney DZ. Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes: cardiovascular and kidney effects, potential mechanisms and clinical applications. Circulation. 2016;134(10):752-72.
39. Neal B, Perkovic V, Mahaffey KW, Fulcher G, Erondu N, Desai M, Shaw W, Law G, Walton MK, Rosenthal N, de Zeeuw D, Matthews DR; CANVAS Program collaborative group. Optimising the analysis strategy for the CANVAS Program - a pre-specified plan for the integrated analyses of the CANVAS and CANVAS-R trials. Diabetes Obes Metab. 2017. doi: 10.1111/dom.12924.
40. Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Stein P, Desai M, Shaw W, Jiang J, Vercruysse F, et al. Rationale, design, and baseline characteristics of the canagliflozin cardiovascular assessment study (CANVAS)-a randomized placebo-controlled trial. Am Heart J. 2013;166(2):217-23.
41. Neal B, Perkovic V, Matthews DR, Mahaffey KW, Fulcher G, Meininger G, Erondu N, Desai M, Shaw W, Vercruysse F, et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial. Diabetes Obes Metab. 2017;19(3):387-93.
42. Tanaka A, Inoue T, Kitakaze M, Oyama J, Sata M, Taguchi I, Shimizu W, Watada H, Tomiyama H, Ako J, et al. Rationale and design of a randomized trial to test the safety and non-inferiority of canagliflozin in patients with diabetes with chronic heart failure: the CANDLE trial. Cardiovasc Diabetol. 2016;15:57.